Trial Outcomes & Findings for A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL (NCT NCT00858117)

Last Updated: 2020-11-06

Results Overview

Response rate (complete remission(CR) + partial remission(PR)) will be, assessed by NCI-WG 1996 criteria with lymphadenopathy and organomegaly measured during physical examination. CR=Absence of lymphadenopathy and constitutional symptoms, Normal CBC (leukocytes ≥ 1500/μl, Platelets \>100,000/μl, Hemoglobin \> 11.0 gm/dl), peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes. PR=absence of constitutional symptoms, ≥ 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value, ≥ 50% reduction in lymphadenopathy, ≥ 50% reduction in size of liver and/or spleen and one of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline platelets \> 100,000/μl or 50% improvement over baseline or hemoglobin \> 11.0 gm/dl or 50% improvement over baseline without transfusions

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

30 participants

Primary outcome timeframe

At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Results posted on

2020-11-06

Participant Flow

The study opened for accrual on 29th March 2005 with the first patient starting treatment 26th September 2005 and an accrual goal of 30 patients. The study closed to further enrollment on the 26th October 2009 with 30 patients treated on study.

Participant milestones

Participant milestones
Measure	Alemtuzumab and Rituximab Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Treatment on Study STARTED	30
Treatment on Study Completed 18 Weeks of Treatment	28
Treatment on Study COMPLETED	28
Treatment on Study NOT COMPLETED	2
Follow up for 5 Years STARTED	30
Follow up for 5 Years COMPLETED	17
Follow up for 5 Years NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Alemtuzumab and Rituximab Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Treatment on Study Adverse Event	2
Follow up for 5 Years Death	4
Follow up for 5 Years No further data collected for study	9

Baseline Characteristics

A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	10 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants

PRIMARY outcome

Timeframe: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Outcome measures

Outcome measures
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Number of Patients Treated With Alemtuzumab and Rituximab Combination With a Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Lymph-adenopathy and Organomegaly Measured During Physical Examination	30 Participants

PRIMARY outcome

Timeframe: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Response rate (complete remission(CR) + partial response(PR)) will be assessed by NCI-WG 1996 criteria with measurements of the lymph nodes and spleen size by CT scans. Best response at any timepoint is captured below. CR= absence of significant lymphadenopathy (e.g. lymph nodes \> 1.5 cm in their greatest transverse diameter) and no hepatomegaly or splenomegaly. PR=reduction in lymphadenopathy as defined by the following: (a) a decrease in lymph node size by 50% or more either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (\< 2cm), an increase of less than 25% was not considered to be significant and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more.

Outcome measures

Outcome measures
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Number of Patients Treated With Alemtuzumab and Rituximab Combination With Response (CR or PR) Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans	21 Participants

SECONDARY outcome

Timeframe: During treatment, 18 weeks

Toxicity data will be collected at visits during 18 weeks of treatment and include adverse events considered at least possibly related to either study drugs (Alemtuzumab and Rituximab) and graded 3-5 using CTCAE 3.0. In general grading is as follows: Grade 1=mild Grade 2=moderate Grade 3=severe Grade 4=life threatening Grade 5=death Reported below are the number of patients who experienced each event

Outcome measures

Outcome measures
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Toxicity of the Study Medications, Alemtuzumab and Rituximab Infection	2 Participants
Toxicity of the Study Medications, Alemtuzumab and Rituximab Neutropenia	9 Participants
Toxicity of the Study Medications, Alemtuzumab and Rituximab Thrombocytopenia	2 Participants
Toxicity of the Study Medications, Alemtuzumab and Rituximab Renal toxicity	1 Participants
Toxicity of the Study Medications, Alemtuzumab and Rituximab Skin rash	1 Participants
Toxicity of the Study Medications, Alemtuzumab and Rituximab Fatigue	1 Participants

POST_HOC outcome

Timeframe: At week 9, and post 18 weeks of treatment, then every 3 months for a year and up every 6 months for up to 2 years

Patients best response to treatment as defined in general as: Complete Remission=Absence of lymphadenopathy and constitutional symptoms, Normal CBC, peripheral blood lymphocytes ≤ 4,000/μl.The marrow sample must be at least normocellular with \< 30% of nucleated cells being lymphocytes. Partial Remission=absence of constitutional symptoms, ≥50%decrease in peripheral blood lymphocyte count, ≥50%reduction in lymphadenopathy, ≥50%reduction in liver and/or spleen size \& 1 of the following: polymorphonuclear leukocytes ≥ 1,500/μl or 50% improvement over baseline, platelets \>100,000/μl or 50%improvement over baseline, hemoglobin \> 11.0 gm/dl or 50% improvement over baseline without transfusions. Stable Disease=Do not meet criteria for complete/partial remission or progressive disease. Progressive Disease= ≥50%increase ≥2 lymph nodes or ≥50% increase in absolute no. of circulating lymphocytes or ≥50% increase in liver and/or spleen size or transformation to a more aggressive histology

Outcome measures

Outcome measures
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Lymphadenopathy and Organomegaly Measured During Physical Examination Complete Remission	18 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Lymphadenopathy and Organomegaly Measured During Physical Examination Partial Remission	12 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Lymphadenopathy and Organomegaly Measured During Physical Examination Stable Disease	0 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Lymphadenopathy and Organomegaly Measured During Physical Examination Progressive Disease	0 Participants

POST_HOC outcome

Timeframe: At week 9, and post-18 weeks then every 3 months for a year and up every 6 months for up to 2 years

Best Response to treatment, in general is defined as: Complete Remission= absence of significant lymphadenopathy and no hepatomegaly/splenomegaly. Partial Remission=reduction in lymphadenopathy as defined by the following: (a) 50% decrease in lymph node size by 50% either in the sum products of up to six lymph nodes, or in the largest diameter of the enlarged lymph node(s) detected prior to therapy; (b) no increase in any lymph node, and no new enlarged lymph node; in small lymph nodes (\<2cm),and a reduction in the noted pretreatment enlargement of the spleen or liver by 50% or more. Stable Disease=not meet criteria for complete/partial remission or progressive disease Progressive Disease=appearance of any new lesion, such as enlarged lymph nodes (1.5cm), splenomegaly, hepatomegaly or other organ infiltrates: (a)50%increase + in greatest diameter of any previous site; (b)50% + increase liver or spleen size.

Outcome measures

Outcome measures
Measure	Alemtuzumab and Rituximab n=30 Participants Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans Complete Remission	7 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans Partial Remission	14 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans Stable Disease	9 Participants
Best Response in Patients Treated With Alemtuzumab and Rituximab Combination Assessed by NCI-WG 1996 Criteria With Measurements of the Lymph Nodes and Spleen Size by CT Scans Progressive Disease	0 Participants

Adverse Events

Alemtuzumab and Rituximab

Serious events: 11 serious events

Other events: 30 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Alemtuzumab and Rituximab n=30 participants at risk Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
Infections and infestations Possible infection with fever	6.7% 2/30 • Number of events 2 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Chronic myelogenous leukemia	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Diffuse large B cell lymphoma	10.0% 3/30 • Number of events 3 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Multiple myeoma	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Urachal adenocarcinoma of the bladder	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Esophageal cancer	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Possible acute renal failure	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	3.3% 1/30 • Number of events 1 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.

Other adverse events

Other adverse events
Measure	Alemtuzumab and Rituximab n=30 participants at risk Administration of Alemtuzumab combined with Rituximab to test the feasibility of combining these two monoclonal antibodies as a first line therapy in patients with B-cell chronic lymphocytic leukemia. Alemtuzumab: Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks Rituximab: Rituximab administered intravenously at 375mg/m2 every 2 weeks (starting week 3) for 18 weeks
General disorders Allergic rhinitis (including sneezing,nasal stuffiness,postnasal drip)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Ear and labyrinth disorders Ear pressure/pain	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Hemoglobin (anemia)	80.0% 24/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Neutrophils (neutropenia)	60.0% 18/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Leukocytes (total WBC)	96.7% 29/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Lymphopenia	100.0% 30/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Platelets (thrombocytopenia)	63.3% 19/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Cardiac disorders Hypotension	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Cardiac disorders Atrial fibrillation	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Cardiac disorders Tachycardia	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Malaise	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Fatigue	40.0% 12/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Fever	50.0% 15/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Insomnia	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Rigors	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Chills	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Sweating	43.3% 13/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Weight loss	30.0% 9/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Shaking	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Injection site reaction/extravasation changes	80.0% 24/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Pruritus/itching	26.7% 8/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Perivascular neutrophilic dermatitis	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Rash	40.0% 12/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Sun burn	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Skin peeling	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Bruising	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Hives	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Alopecia	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Skin and subcutaneous tissue disorders Blotchiness	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Endocrine disorders Hot flashes/flushes	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Anorexia	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Constipation	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Colitis	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Diarrhea	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Flatulence	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Mucositis/stomatitis	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Heartburn/dyspepsia	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Nausea	16.7% 5/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Dry lips	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Taste alteration(dysgeusia)	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Vomiting	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Scratchy throat	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Dysphagia (difficulty swallowing)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations Upper respiratory infection	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations Lung (pneumonia)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations Upper airway infection NOS	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations Adenovirus	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations NOS	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Infections and infestations CMV positive	16.7% 5/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders Edema	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Blood and lymphatic system disorders :Edema:trunk/genital	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Alkaline phosphatase	30.0% 9/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Transaminase	36.7% 11/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Bicarbinate high	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders High GFR	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders ALT, SGPT (serum glutamic pyruvic transaminase)high	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders AST, SGOT (serum glutamic oxaloacetic transaminase) high	16.7% 5/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Albumin, serum-low (hypoalbuminemia)	46.7% 14/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Bilirubin (hyperbilirubinemia)	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders High LDH	20.0% 6/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Increased BUN	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Creatinine	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Calcium, serum-low (hypocalcemia)	43.3% 13/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Cholesterol, serum-high (hypercholesteremia)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Glucose, serum-high (hyperglycemia)	80.0% 24/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Glucose, serum-low(hypoglycemia)	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Magnesium, serum-high (hypermagnesemia)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Magnesium, serum-low(hypomagnesemia)	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Phosphate, serum-low (hypophosphatemia)	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Potassium, serum-high(hyperkalemia)	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Potassium, serum-low(hypokalemia)	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Sodium, serum-high(hypernatremia)	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Sodium, serum-low(hyponatremia)	36.7% 11/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Metabolism and nutrition disorders Uric acid, serum-high (hyperuricemia)	6.7% 2/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Nervous system disorders Neuropathy:sensory	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Nervous system disorders Motor - hand tremors	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Psychiatric disorders Dizziness	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Psychiatric disorders Mood alteration - Anxiety	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Psychiatric disorders Mood alteration - Depression	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Nervous system disorders Syncope (fainting)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Musculoskeletal and connective tissue disorders Muscle aches	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Ear and labyrinth disorders Pain : ear	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Gastrointestinal disorders Abdomen pain NOS	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Musculoskeletal and connective tissue disorders Muscle cramps	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Hematuria	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Musculoskeletal and connective tissue disorders Leg cramps	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Nervous system disorders Headache	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders GENERAL- Pain	36.7% 11/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Respiratory, thoracic and mediastinal disorders Cough	20.0% 6/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Respiratory, thoracic and mediastinal disorders Dyspnea on exertion	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Eye disorders Flashing lights	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Eye disorders Watery eye (epiphora, tearing)	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Renal failure	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Polyuria	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Dysuria	10.0% 3/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Renal incontinence	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Renal and urinary disorders Renal insufficiency	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Flu-like syndrome	13.3% 4/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Nasal drip	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
General disorders Nasal congestion	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.
Reproductive system and breast disorders vaginal burning	3.3% 1/30 • Patients were assessed for adverse events (including serious adverse event (SAE) due to hospitalizations) and data was collected, from the time of treatment initiation through 18 weeks of treatment. All cause mortality was collected during 18 weeks of treatment and through 5 years of follow up. Additionally, new cancer SAEs were collected through treatment and through 5 years of follow up.

Additional Information

Olga Frankfurt, MD

Northwestern University

Phone: 312 695 6180

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place